ALFSG Ancillary Study Guidelines

The Acute Liver Failure Study Group (ALFSG) is a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded network of 15 clinical centers that collect biological samples and data on patients with varying etiologies of Acute Liver Failure (ALF). The coordinating center is located at the UT Southwestern Medical Center (UTSW) under the leadership of Dr. William M. Lee and has research records on over 2000 adult ALF patients. In addition to the extensive database, the ALFSG has accrued biosamples on more than 80% of these patients, including serum, plasma, urine, DNA and tissue. All are valuable biosamples and the minimum amount required to perform the proposed study is required in the study protocol submission.

Internal and external investigators are invited to submit proposals to the ALFSG Ancillary Studies Committee for original research that may or may not be directly related to acute liver failure. For example, studies to date have looked at the appearance of auto-antibodies in patients with acute liver failure. All ancillary study submissions from investigators in the ALFSG will be forwarded to the Ancillary Studies Committee directly for review. Those from outside the ALFSG will require an investigator collaborator from within the group. This investigator will serve as liaison to the investigator proposing the new study. The Ancillary Studies Committee is comprised of a chair, Dr. Iris Liou, 7 clinical center principal investigators, a biostatistician, and a non-voting project officer from the NIH. Drs. Lee or Liou can provide names of potential ALFSG co-investigators and review the aims and methods of previously approved ancillary studies to minimize any potential conflicts. Funding requests are not handled directly by the group, but should be submitted to NIDDK via the National Institutes of Health (NIH) website.

All ancillary studies which are not directly related to the primary aims of the ALFSG protocol will be reviewed by the Ancillary Studies Committee. There will be two in-depth reviewers who critically review and rank the proposal on a priority scale of 1 to 5 followed by a committee wide discussion. Criteria used in the review process will include:

Merit of scientific aims, study methods, and potential impact

Feasibility

Impact on ALFSG resources

Track record of investigators

Potential overlap with other approved studies

Ancillary study proposal submission

1. All ancillary study proposals must be submitted to the committee chair, Iris Liou MD through the coordinating center at UTSW.

3. The committee meets quarterly to review all submitted proposals and return comments and suggestions to the principal investigator in a timely fashion (usually within 6 weeks of submission). A final recommendation consisting of the following categories will be made to the Steering Committee:

Approval

Deferral

Denial

4. Proposals coming from clinical center investigators of the ALFSG will receive priority over external applicants.

Update

All individuals with an approved ancillary study are required to provide an update. In order to standardize the reporting of studies, all reports are to be submitted within six months of sample receipt and contain the following format:

Title of study, investigators, date of initial approval

Number of patients enrolled/ samples analyzed

Preliminary or final results

Copies of all abstracts and/or publications submitted

Detailed timeline for completing the study

It is expected that most ancillary studies should be completed within 1 calendar year of receiving samples. Furthermore, it is the committee’s expectations that negative as well as positive studies move forward to final manuscript publication.

NOTE: Failure to submit an update within 6 months will preclude further release of samples and/or data to the investigator. In addition, collaborating investigators who fail to provide an update will be reviewed by the ALFSG Executive Committee for further action.

Please use the Ancillary Studies Proposal Template for study submission.